Safety and Efficacy of NT 201, Free of Complexing Proteins, in the Treatment of Glabellar Frown Lines
October 29, 2012 updated by: Merz Pharmaceuticals GmbH
NT 201 is a Botulinum Toxin Type A Preparation Free of Complexing Proteins. Injected Into the Muscle, NT 201 Causes a Reversible Local Relaxation of the Injected Muscle. Botulinum Toxin Type A is Widely Used for Aesthetic Treatment of Mimic Wrinkles. This Study Will Investigate the Safety and Efficacy of NT 201 in the Treatment of Glabellar Frown Lines.
NT 201 is a Botulinum toxin type A preparation free of complexing proteins.
Injected into the muscle, NT 201 causes a reversible local relaxation of the injected muscle.
Botulinum toxin type A is widely used for aesthetic treatment of mimic wrinkles.
This study will investigate the safety and efficacy of NT 201 in the treatment of glabellar frown lines.
Study Overview
Study Type
Interventional
Enrollment (Actual)
108
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hessen
-
Bad Soden, Hessen, Germany, 65812
- Dr. Matthias Imhof, Medico Palais Bad Soden
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 61 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- moderate to severe glabellar frown lines at maximum frown ((severity score of 2 or 3 on Facial Wrinkle Scale(FWS)as assessed by the investigator's rating: 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe'
- Stable medical condition
- Age: between 18 and 65 years (inclusively)
Exclusion Criteria:
- Previous treatment with Botulinum toxin of any serotype in the upper third part of the face within the last 6 month
- Previous treatment with biodegradable fillers in the glabellar area within the last 12 month
- Previous insertion of permanent material in the glabellar area, including fat graft (regardless of the time between previous treatment and this study)
- Any surgery in the glabellar area including surgical removal of the corrugator, procerus, or depressor supercilii muscles or a combination of these, or scars in the glabellar area
- Any other planned cosmetic procedure in the upper third part of the face during the trial period
- Inability to substantially lessen glabellar frown lines even by physically spreading them apart
- Marked facial asymmetry or ptosis of eyelid and/or eyebrow
- History of facial nerve palsy
- Any infection in the area of the injection sites
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Investigator's assessment
Time Frame: 4 weeks after initial injection session
|
4 weeks after initial injection session
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Matthias Imhof, MD, Ästhetische Dermatologie, Medico Palais Bad Soden
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2008
Primary Completion (Actual)
January 1, 2009
Study Completion (Actual)
January 1, 2009
Study Registration Dates
First Submitted
June 2, 2008
First Submitted That Met QC Criteria
June 9, 2008
First Posted (Estimate)
June 10, 2008
Study Record Updates
Last Update Posted (Estimate)
October 30, 2012
Last Update Submitted That Met QC Criteria
October 29, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MRZ 60201 GL_3001
- 2008-000549-73 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.